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Copy of Template: iPad

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christelle gedeon

on 3 December 2013

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Transcript of Copy of Template: iPad

Legal & Regulatory Considerations
Health Canada Regulation of Mobile Medical Apps as Medical Devices
The Current Regulatory Landscape
Is it a Medical Device?
If so, what does it mean for:

Mobile Medical Apps and User/Patient Privacy
Section Name Here
The Current Regulatory Landscape
Is it a Medical Device?
The Manufacturer of a Mobile Medical App has primary regulatory responsibility for the Device
The Manufacturer is the person who sells the device under their own name or brand (or one controlled by them) and is responsible for its design or specifications
Not necessarily the Mobile Medical App developer
What does this mean for Manufacturers, Distributors and Users?
Mobile Medical Applications
Timothy Squire
Partner, Fasken Martineau
Co-Chair, International Life Sciences Group

Toronto, December 4, 2013

Medical Devices are regulated under the Medical Devices Regulations made pursuant to the Canadian Food an Drugs Act
The Regulations impose legal obligations on manufacturers, importers and distributors of Medical Devices related to:
Safety and Efficacy
Quality Management
Record Keeping
Problem Reporting and Recalls
Two types of Licenses are prescribed by the Regulations:
Medical Device License (MDL) - product specific
Medical Device Establishment License (MDEL) - activity specific
Medical Devices and stakeholders are under the jurisdiction of Health Canada
Subject to broad inspection and enforcement powers

Defintion of "Medical Device" - s.1 Regulations & s.2 of the Act:

Intended use is determinative
The medical use can be peripheral to the primary means of treatment, diagnosis, mitigation or prevention
Users can be healthcare professionals, patients and/or consumers
This definition casts a very wide net
Examples - Are they Medical Devices?
Mobile Apps that are connected to an external device (device system)
Mobile Apps that utilize a built-in mobile device function (camera, microphone, speaker, motion sensor, GPS)
Mobile Apps that process inputted data and provide a specific analysis, diagnosis, recommendation or other output
Resource Apps
On September 25, 2013, the FDA published "Mobile Medical Applications - Guidance for Industry and FDA Staff"
Outlines the FDA's view of what is, and what is not, a Medical Device under U.S. law
Identifies Mobile Medical Apps for which the FDA intends to exercise "enforcement discretion" (i.e. will not enforce)
No similar guidance from Health Canada is currently planned
Medical Devices are classified under the Regulations according to risk profile - Class I to IV
Classification determines level of regulatory oversight
Class I Medical Devices do not require an MDL
Class II to IV Medical Devices require an MDL
Classification involves a cases-by-case assessment using the classification rules in the Regulations
General guidelines:
Mobile Medical Apps that are an accessory to a device system are classified according to the risk profile of the system
Stand-alone Mobile Medical Apps that image or monitor a physiological process for a diagnostic purpose are Class II devices, unless they comprise an IVDD.
All other Mobile Medical Apps are Class I Devices (and do not require an MDL)
Under the Regulations, the Manufacturer of a Mobile Medical App (regardless of risk classification) is required to:
Ensure the App meets the safety and effectiveness requirements (including software validation)
Label the App according to labeling requirements
Maintain distribution records
Record and investigate product complaints
Report adverse events
Initiate and report recalls when required
Manufacturers of Class II to IV Mobile Medical Apps must also:
Obtain an MDL for the Mobile Medical App
Hold an ISO 13485 QMS Certificate from a recognized registrar
Class II MDL application is a standard form (30 day processing target - $365 fee)
Class III and IV MDL applications involve the submission of data ( 120 and 135 day processing targets - $5,255 - $20,840 fee)
It is an offence to advertise or sell an unlicensed Class II, III and IV Medical Device
Any person who sells a medical device must hold an MDEL
Sale can include transfer for no consideration
This applies to Manufacturers and Distributors, but there are several important exemptions
MDEL Application is a standard form document:
Attestation from a senior officer
$7,500 fee (approx)
120 target turn-around
Subject to inspection
MDEL exemptions:
Healthcare Facilities
Manufacturers of Class II to IV Devices
Manufacturers of Class I Devices

if they distribute solely through a person who holds an MDEL
Manufacturers of Class I Mobile Medical Apps require an MDEL if they distribute directly or through a Retailer

Users of Mobile Medical Apps are not directly governed by the Regulations or the Act
Users are potentially impacted by Health Canada enforcement activity
Health Canada warned Healthcare Facilities in December 2009 and again in September 2013
Exercise diligence
Connectivity of Mobile Medical Apps raises many user/patient privacy issues
Manufacturers and Distributors are subject to federal Personal Information Protection and Electronic Documents Act ("PIPEDA")
Healthcare Professionals (and in some cases Manufacturers and Distributors) are subject to Ontario Personal Health Information Protection Act ("PHIPA")
Manufacturers of Mobile Medical Apps collect User information for many reasons:
Customize or enhance functions
Compilation of data
PHIPA imposes a wide range of restrictions on Health Information Custodians (e.g. Healthcare Professionals and Facilities), including:
Establishing Information Practices in a Privacy Policy regarding the collection, use, disclosure and disposal of personal health information
Maintaining the accuracy and security of personal health information
Obtaining patient consent to the collection, use and disclosure of personal health information when required
Mobile Medical App functionality is replacing conventional means of handling personal health information
Health Information Custodians should:
Specifically address Mobile Medical Apps in their required Privacy Policies
Source Mobile Medical Apps that will ensure PHIPA compliance
Include functionality specifications for PHIPA compliance in RFP's
Ensure contracts with Mobile Medical App Manufacturers and Distributors contain privacy provisions
If the information can identify the individual, PIPEDA requires (among other things) that:
The purpose for which the information is collected is clearly disclosed
The consent of the User is obtained (express consent required for sensitive information such as personal health information)
The information is only used or disclosed for the stated purpose
PHIPA (Regs) also imposes restrictions on those who supply services to enable the collection and use of personal health information by Health Information Custodians
Can apply to Mobile Medical App Manufacturers and Distributors
If the service provider has access to personal health information:
It cannot be used except as necessary to provide the service
It cannot be disclosed
It is only made accessible to employees who agree to comply with these restrictions
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